Job Description :
OHSP Coordinator II



The Office of Human Subjects Protection (OHSP) Coordinator II is responsible for the coordination and management of the St. Jude IRB in order to comply with institutional and IRB policies and procedures, as well as, federal, state and local rules and regulations and ethical principles regarding human subject’s research. Performs quality control functions and ensures research activities involving human subjects under the jurisdiction of the St. Jude IRB are conducted in a manner that protects the safety, rights, and welfare of participants.

Serves as a central resource for the research community to provide expertise and regulatory guidance on complex issues, operational goals, ethical considerations, institutional and St. Jude Human Research Protection Program (HRPP) and IRB policies related to human subjects protections in research. Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements. Collaborates with internal and external customers to develop and evaluate services for the improvement of the St. Jude HRPP utilizing and developing standardized organization-wide guidelines. Actively Participates in the Continuous Quality Improvement (CQI) program for the St. Jude HRPP.

Minimum Education:

Bachelor's degree or foreign equivalent in an appropriate scientific or business/public administration

Minimum Experience:

Three(3) years of experience in the area of human subjects’ protection or clinical trials including one (1) year of experience in a regulatory affairs, quality assurance, or IRB administration.

This position also requires experience in each of the following:

1)Federal regulations and guidelines governing clinical trials (ICH-GCP, Belmont Report, HIPAA, Common rule -45 CFR 46, FDA regulations 21CFR 11, 50, 54, 56, 312, 812 and CLIA)

2) Working with electronic IRB management review systems

3) Utilizing institutional policies, IRB policies and procedures, and institutional systems to guide investigations in the conduct of human subject’s research and ensure compliance

4) Providing authoritative guidance to clinical investigators from concept to protocol development based on study parameters

5) Knowledge of medical, scientific, and technical terminology used in hematology/oncology research protocols and medical records

6) Evaluating IRB applications using 45 CFR 46 regulations and identifying potential regulatory issues prior to review by the IRB

7) Reviewing and creating informed consent documents/processes/guidelines per Central and local IRB’s template and SOPs, to assure that it meets all regulatory requirements for IRB submission and approval

8) Conducting directed audits of oncology studies and resolution of compliance issues for findings that do not conform to federal, state and local laws, institutional policies and procedures and IRB policies and procedures.

Client : St. Jude Children's Research Hospital